Mum on drug trial to treat ectopic pregnancy is one of thousands taking part in Buckinghamshire NHS research

Date:18 July 2018

A mother who took part in an NHS trial to treat an ectopic pregnancy has welcomed the news that more than 4,000 people took part in Buckinghamshire NHS research in 2017/18.

Lorraine Walters of Winslow, near Buckingham, participated in a drug study at Stoke Mandeville Hospital after she was diagnosed with an ectopic pregnancy - where the fertilised egg does not attach to the womb - in April.

She urged others to consider taking part in research after figures showed 4,024 participants took part in 79 studies supported by the National Institute for Health Research (NIHR) at Buckinghamshire Healthcare NHS Trust.

Miss Walters, 34, said: “I would definitely recommend investigating research and finding out more, even if you don’t decide to go on a trial. I would consider taking part again.”

An ectopic pregnancy is when a fertilised egg implants itself outside of the womb, usually in one of the fallopian tubes. There is no chance of this pregnancy surviving and it can be life threatening if left untreated.

If detected early, a single dose of drug methotrexate is given. However, if this does not terminate the pregnancy within two weeks, another dose or surgery may be needed.

The GEM 3 study is looking at whether lung cancer drug gefitinib taken alongside methotrexate can stop an ectopic pregnancy developing without surgery or further medication.

Miss Walters, 34, was admitted to hospital ward for sepsis (blood poisoning) and was given a blood test which revealed the ectopic pregnancy.

The mother-of-two said: “I was in a lot of pain, but because I had sepsis at the time I couldn’t pinpoint whether it was that or the ectopic pregnancy. Had I just been dealing with the ectopic pregnancy, my symptoms may have been different.”

After her sepsis was treated with antibiotics, Miss Walters was discharged to the Aylesbury hospital’s maternity ward.

She said: “The research midwives approached me and told me I could either take part in a new drug trial or have surgery. The new drug sounded like it would get everything over with quicker in the least invasive way possible, so I thought it was a great idea.

“I’m quite a helper. If something good can come out of something bad and help more people, it’s a great thing to do.

“I am also quite a curious person and I thought if the trial drug would make my life a bit easier, then why not?”

Women being treated with methotrexate are invited to take part in the study and are given seven tablets of gefitinib or a placebo (dummy drug) to take daily. Neither researchers nor participants are told which they are getting, so they can be compared without bias.

Miss Walters’ pregnancy ended two weeks after enrolling on the trial, without the need for surgery or further drug treatments.

Miss Walters, who was eight weeks pregnant at the time of her diagnosis, said: “I hadn’t had a lot of emotional attachment to the pregnancy as I didn’t know about it before I found out it wasn’t viable.

“It was a bit different from having a miscarriage. This was more of a medical issue than an emotional one.”

She said: “I feel very lucky, fortunate and humbled my diagnosis and treatment happened when they did and that I’m okay.”

The study is led by the University of Birmingham Clinical Trials Unit and sponsored by the University of Edinburgh and NHS Lothian.

The NHS supports research by asking patients and healthy volunteers if they wish to take part in trials to enable participants to access new NHS treatment and care options.

Figures released today also show the extent of research in other NHS settings in Buckinghamshire.

Oxford Health NHS Foundation Trust recruited 2,242 participants to 60 studies, putting it third for the number of studies and fifth for the number of participants, out of all mental health trusts in England. The trust provides physical, mental health and social care in Oxfordshire, Buckinghamshire, Swindon, Wiltshire, Bath and North East Somerset.

Professor John Geddes, Director of Research and Development at Oxford Health, said: “We are fully committed to working with the clinical services to expand the opportunities for participation in research to all our patients.

“The complex problems of mental disorders and dementia deserve the same research excellence as in other areas of health care. Patient participation in research continues to be one of the best ways to drive up quality, promote innovation and ensure that the research we conduct is as useful as it can be.”

A further 20 studies involving 311 participants took place in Buckinghamshire’s GP practices.

Nicola Higgins, Research Operations Manager for Buckinghamshire Healthcare NHS Trust, said: “We would like to take this opportunity and say ‘thank you’ to all the Buckinghamshire residents who have made a difference to healthcare through research at our Trust this year, and having listened to our patient user group, we are now planning ways to build on the involvement in research from GP practices.

“I would like give another big ‘thank you’ to our research team, who were highlighted in this year’s staff survey as being the most engaged within the entire Trust; a phenomenal achievement in such a demanding environment and when compared to 101 other teams.”

Prof Belinda Lennox, Clinical Director for the NIHR Clinical Research Network Thames Valley and South Midlands, said: “The Thames Valley is leading the way in delivering life saving research in the NHS. These league table results show the huge range of research studies that are being undertaken across our region in GP practices and in hospitals across our region.

“Over 40,000 people have taken part in NHS research in the Thames Valley over the last year, all of them helping to increase our understanding of illness and develop the treatments of the future. As the NHS celebrates its 70th birthday, public participation in research is helping the health service develop and strengthen for the future.”